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中国无锡,
2026年6月30日
全球领先的合同研究、开发和生产(CRDMO)服务公司药明生物(WuXi Biologics, 2269.HK)宣布,其位于无锡的两家生产厂——生物药原液二厂(MFG2)和生物药制剂一厂(DP1),以及制剂包装中心(DPPC)已获得巴西国家卫生监督管理局(ANVISA)GMP认证,为一款用于肿瘤免疫治疗的抗PD-L1单克隆抗体提供涵盖原液和制剂的端到端商业化生产服务。
在为期5天的检查中,MFG2、DP1和DPPC均以“零发现项”顺利通过ANVISA评估。此次检查进一步体现了药明生物完善的质量管理体系、成熟的GMP运行机制和高效的跨职能协同能力,也验证了公司赋能客户开展全球商业化生产的综合实力。
本次通过检查的两家生产厂和制剂包装中心在药明生物全球生产网络中各具优势。MFG2专注于规模化生物药原液生产,具备支持商业化供应的稳定产能;DP1可提供覆盖临床及商业阶段的制剂生产能力;DPPC则为客户提供符合全球主要市场法规要求的定制化包装解决方案。依托药明生物全球GMP生产网络的协同运作,可为创新生物药提供高效、一体化的端到端生产支持。
陈智胜
博士
药明生物首席执行官
此次获得ANVISA GMP认证,是药明生物持续践行全球质量与合规标准的重要体现,并进一步验证了我们在厂房设施、质量体系和GMP执行方面的国际化水平。未来,我们将继续依托国际一流的质量体系和端到端生产能力,助力客户拓展包括拉美在内的全球市场,加速创新生物药惠及患者,为提升药物可及性和可负担性贡献力量。
药明生物始终坚持严格的行业质量标准,并保持卓越的质量记录。截至2025年12月底,公司已成功通过46次监管机构检查,包括22次FDA和EMA检查,厂房许可批准达136次,并且在FDA的药品上市批准前检查(PLI)中保持100%通过率。此外,公司还通过了全球客户超过1800次的GMP质量审计,包括超230次欧盟质量受权人(Qualified Persons)审计。目前,药明生物在全球拥有15个GMP认证的生物药原液及制剂生产厂,其国际一流的质量体系与合规能力是赢得客户信任的基石。
关于药明生物
药明生物(股票代码:2269.HK)是一家全球领先的合同研究、开发和生产(CRDMO)公司。公司通过开放式、一体化生物制药能力和技术赋能平台,提供全方位的端到端服务,帮助合作伙伴发现、开发及生产生物药,实现从概念到商业化生产的全过程,加速全球生物药研发进程,降低研发成本,造福全球病患*。
依托连结中国、美国、爱尔兰、德国和新加坡的全球网络,药明生物汇聚逾13000名员工,包括在生物药研发及生产、技术创新和卓越运营等领域的行业专家与科学家。公司凭借领先的技术平台和精深的专业能力,为客户提供高效、成本优势、规模化的生物药解决方案,精准满足不同阶段的客户需求。此外,公司还将数字化能力与基础设施系统性嵌入生物药研发、实验室运营与生产制造的全价值链,把数据、计算与预测能力转化为更透明的客户合作体验、更快的研发进程、更智能的运营管理与更高效的生产交付。截至2026年4月底,药明生物帮助客户研发和生产的综合项目高达982个,其中包括78个临床III期项目,25个商业化生产项目,复杂分子项目合计占比超过公司总项目数50%。
药明生物以可持续发展为长期业务增长的基石。公司持续推动绿色创新技术,为全球合作伙伴提供先进的端到端绿色CRDMO解决方案,同时在ESG方面不断取得卓越成就。秉承创造共享价值的理念,公司携手利益相关方构建可持续发展生态,通过负责任运营模式推动社会价值与生态效益双提升,实现全价值链的协同赋能。
更多信息,请访问:www.wuxibiologics.com
*荣膺“2026年度生物药CDMO领军企业奖”(大型CDMO公司类别)(Life Science Connect / Outsourced Pharma)
*荣膺“2026最佳合同开发和生产企业奖”(ABEA)
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WuXi Biologics Receives Brazil ANVISA GMP Certification to Enable Global Commercial Manufacturing of Innovative Cancer Immunotherapy
Wuxi, China,
June 30, 2026
WuXi Biologics (2269.HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), announced that two of its manufacturing facilities in Wuxi — Drug Substance Facility 2 (MFG2) and Drug Product Facility 1 (DP1) — together with its Drug Product Packaging Center (DPPC), have received GMP certification from Brazil's Agência Nacional de Vigilância Sanitária (ANVISA). The certification positions WuXi Biologics to provide end‑to‑end commercial manufacturing services — covering both drug substance and drug product — for an anti-PD-L1 monoclonal antibody used in cancer immunotherapy.
Based on the five-day inspection, MFG2, DP1 and DPPC successfully passed ANVISA's assessment with zero findings. The inspection results demonstrate WuXi Biologics' robust quality management system, mature GMP execution, and efficient cross-functional collaboration, while verifying the company's comprehensive capabilities to support client needs for global commercial manufacturing and supply.
Within WuXi Biologics' global GMP manufacturing network, MFG2, DP1 and DPPC collectively provide integrated, end-to-end capabilities spanning large-scale biologics drug substance manufacturing, clinical and commercial drug product fill-finish, and customized packaging, meeting regulatory requirements across major markets worldwide. Together, these capabilities enable seamless manufacturing and reliable commercial supply for innovative biologic therapies.
Dr. Chris Chen
CEO
WuXi Biologics
Receiving ANVISA GMP certification reflects WuXi Biologics' continued commitment to global quality and compliance standards, and further validates our international standards across facilities, quality systems, and GMP execution. Looking ahead, we will continue to leverage our world-class quality system and end-to-end manufacturing capabilities to enable clients' global commercialization strategies, including entry into Latin America. By accelerating the delivery of high-quality, affordable biologics, we are helping to broaden access to innovative biologics for patients around the world.
WuXi Biologics has consistently demonstrated a proven track record of adherence to the industry's rigorous quality standards. As of the end of 2025, it has successfully passed 46 regulatory inspections, including 22 conducted by the FDA and EMA, and secured 136 facility license approvals. The company also holds an industry-leading record, achieving a 100% pass rate for FDA Pre-License Inspection (PLI). In addition, WuXi Biologics has passed more than 1,800 GMP quality audits by global clients, including over 230 audits by EU Qualified Persons. Currently, the company operates 15 GMP-certified drug substance and drug product facilities within its global network. Its world-class quality and compliance capabilities underpin long-standing trust from clients worldwide.
About
WuXi Biologics
WuXi Biologics (stock code: 2269.HK) is a leading global Contract Research, Development and Manufacturing Organization (CRDMO) offering end-to-end solutions that enable partners to discover, develop and manufacture biologics – from concept to commercialization – for the benefit of patients worldwide*.
With over 13,000 employees in China, the United States, Ireland, Germany, and Singapore, including experts and scientists in biologics R&D and manufacturing, technology innovation, and operational excellence, WuXi Biologics leverages its technologies and expertise to deliver efficient, cost-effective, and scalable biologics solutions tailored to meet clients'needs. By embedding digital capability and infrastructure across the full biopharmaceutical value chain, the company turns data, computation, and prediction into transparent client experience, faster development, intelligent operations, and more efficient manufacturing. As of April 30, 2026, WuXi Biologics is supporting 982 integrated client projects, including 78 in Phase III and 25 in commercial manufacturing, with complex modalities representing more than half of the entire project portfolio.
WuXi Biologics regards sustainability as the cornerstone of long-term business growth. The company continuously drives green technology innovations to offer advanced end-to-end Green CRDMO solutions for its global partners while consistently achieving excellence in Environment, Social and Governance (ESG). Committed to creating shared value, it collaborates with all stakeholders to foster positive social and environmental impacts and promote responsible practices that empower the entire value chain.
For more information about WuXi Biologics, please visit: www.wuxibiologics.com
*The winner of the "2026 Biologics CDMO of the Year" (Large CDMOs) (Life Science Connect / Outsourced Pharma)
*The winner of the "2026 Best Contract Development & Manufacturing Organization Award" (ABEA)
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